Stephen Donnelly (Wicklow, Fianna Fail)
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The Medical Cannabis Access Programme (MCAP) was established as a result of recommendations by the Health Products Regulatory Authority in their “Cannabis for Medical User – A Scientific Review”.

The review stated that if the policy decision is to make cannabis available for medical purposes, the HPRA advised that it should recognise patient need, but be evidence based. It was advised, that treatment with cannabis be only permitted under a controlled access programme for the treatment of patients with the following medical conditions which have failed to respond to standard treatments;

- spasticity associated with multiple sclerosis;

- intractable nausea and vomiting associated with chemotherapy;

- evere, refractory (treatment-resistant) epilepsy.

Subsequently the Minister for Health established an Expert Reference Group to advise on the development of a Medical Cannabis Access Programme. This Group developed detailed Clinical Guidelines for the MCAP to be followed by clinicians, which contained inter alia guidance on ingredient combinations that are recommended for each of the three indications included in the MCAP.

The Department is currently working to commence a new clinical review that will continue the work of the previous clinical expert group. This review will seek to build on evidence found in the earlier study and will assess if there is new information to support the addition of any other clinical indications to the MCAP.

The MCAP is a 5-year pilot programme. The purpose of the programme is to facilitate access to acceptable cannabis-based products for medical use that are of a standardised quality and which meet the requirements outlined in the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (as amended).

There are currently six products assessed by the HPRA for inclusion in Schedule 1 of the Regulations, more products are currently being assessed by the HPRA. It is open to any supplier or producer to apply to the HPRA to have their products assessed for inclusion in the programme.

On 19 July, I announced that the MCAP was now open for medical consultants to make an application for themselves and their patients to be registered for the programme.

Registration by consultants and their patients on the Cannabis for Medical Use Register, to be operated by the HSE, is required for the prescribing of cannabis-based products under the MCAP.

The Misuse Of Drugs (Prescription And Control Of Supply Of Cannabis For Medical Use) Regulations 2019 (S.I. 262/2019) defines the cannabis-based product or preparation that can be used in the Medical Cannabis Access Programme.

A prospective supplier can apply to the Health Products Regulatory Authority (HPRA) to have a product considered for inclusion in the Schedule of ‘specified controlled drugs’ in the Regulations. As specified controlled drugs will fall under schedule 2 to the Misuse of Drugs Regulations 2017. A controlled drugs licence, processed by the HPRA, on behalf of the Minister, is also required for possession, supply or import of such cannabis products. The onus is on suppliers to make an application.

Details on how to apply for a licence to possess, supply or import medical cannabis products for use under the Medical Cannabis Access Programme in accordance with the requirements for schedule 2 products in the Misuse of Drugs Regulations 2017 can be found in the operator guidance issued by the HPRA.